Index

A

Access to quality health care, 39, 40, 47

Access to transplantation

current system performance, 1, 11

determinants of, 6-7, 12, 39, 45, 47

Final Rule effects, 3, 27-28, 46

Final Rule goals, 2, 26

Medicaid as factor in, 45-46

OPTN responsibilities in improving, 26

patient's travel distance as factor in, 44-45

socioeconomic differences in, 39-40, 41

waiting time as measure of, 10

Accountability, 131, 132

African Americans

access to transplantation, 39, 40, 41, 42, 44

donation rate, 33

histocompatibility testing, 42

organ donation rates, 51-52, 53, 56

posttransplant survival rate, 42, 98

transplantation patterns, 11

waiting times, 40

Age of donors, 50, 51

graft survival risk, 93

Age of transplant patient

likelihood of transplantation and, 86

posttransplant survival rate, 98

pretransplantation mortality risk, 86

status 1 patient outcomes, 69, 86

status 2 patient outcomes, 72, 86

status 3 patient outcomes, 76, 86

Allocation

current concerns, 2, 36, 38

current system, 5, 34-37

Final Rule goals, 2, 24

patient status as criterion for, 36-37

policies, effects on donation rates, 52-53

policy development, 25-26

recommendations for criteria, 90

system evaluation, methodology for, 6

system evolution, 18-19

waiting time as criterion for, 10-11, 35, 87, 90

See also Organ allocation areas

Alternative local units, 32

Asian donors, 51

Assessment, medical

cost of, 124

current inadequacies in, 24, 36

determination of organ acceptability, 93

standardization, 26, 36



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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule Index A Access to quality health care, 39, 40, 47 Access to transplantation current system performance, 1, 11 determinants of, 6-7, 12, 39, 45, 47 Final Rule effects, 3, 27-28, 46 Final Rule goals, 2, 26 Medicaid as factor in, 45-46 OPTN responsibilities in improving, 26 patient's travel distance as factor in, 44-45 socioeconomic differences in, 39-40, 41 waiting time as measure of, 10 Accountability, 131, 132 African Americans access to transplantation, 39, 40, 41, 42, 44 donation rate, 33 histocompatibility testing, 42 organ donation rates, 51-52, 53, 56 posttransplant survival rate, 42, 98 transplantation patterns, 11 waiting times, 40 Age of donors, 50, 51 graft survival risk, 93 Age of transplant patient likelihood of transplantation and, 86 posttransplant survival rate, 98 pretransplantation mortality risk, 86 status 1 patient outcomes, 69, 86 status 2 patient outcomes, 72, 86 status 3 patient outcomes, 76, 86 Allocation current concerns, 2, 36, 38 current system, 5, 34-37 Final Rule goals, 2, 24 patient status as criterion for, 36-37 policies, effects on donation rates, 52-53 policy development, 25-26 recommendations for criteria, 90 system evaluation, methodology for, 6 system evolution, 18-19 waiting time as criterion for, 10-11, 35, 87, 90 See also Organ allocation areas Alternative local units, 32 Asian donors, 51 Assessment, medical cost of, 124 current inadequacies in, 24, 36 determination of organ acceptability, 93 standardization, 26, 36

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule B Belzer UW solution, 17 Biological constraints data collection for evaluating, 94 retrieval and preservation of organs, 91 size of organ allocation areas, 94 Blood type posttransplant survival rate and, 98 pretransplant mortality, 86 status 1 patient outcomes, 69, 86 status 2 patient outcomes, 72, 86 status 3 patient outcomes, 76, 86 transplantation rate and, 86 Bone marrow transplantation. See National Marrow Donor Program C Caucasian donors, 50 Cold ischemic time. See Ischemic time Compliance, medication, 41 Computer simulation, 95-96 Confidentiality, 3, 28 CONSAD computer model, 96 Cost of transplantation components, 123, 124, 130 data sources, 124 definitions, 123 determinants of, 13 effects of broader sharing, 123, 129-130 Final Rule effects, 3, 13-14, 27-28, 123, 127, 128, 129, 130 organ acquisition, 129-130 per transplant, 124 posttransplantation compliance, 41 severity of patient illness, 127-129 sources of variation, 124 D Delayed graft function, 92 Demand for organ transplantation, 2, 17-18, 51 Donation rates, 2 correlates of, 51-52 current status, 50-51 demand and, 18, 51 determinants of, 12, 33, 49, 50, 56, 59 donor age, 50 educational interventions to increase, 53, 56 effects of allocation policies, 52-53 effects of broader sharing, 49, 50, 51, 52-53, 59 Final Rule effects, 3, 12, 27-28, 49 growth of, 18, 50, 51, 53 OPO performance evaluation, 58-59 potential, 50, 58 racial differences, 50-52, 53, 56 strategies to increase, 56-58, 59 E Equity in allocation current concerns, 2, 23 current system performance, 1 determinants of, 12 outcome variations by patient status, 68, 78, 86 socioeconomic differences in access, 39-40 F Family of organ donor decision making processes, 51 outreach strategies to increase organ donations, 56-57 Final Rule concerns about, 3, 26-27 effects on access, 11-12, 39-40, 46 effects on cost, 13-14, 123, 127, 128, 129, 130 effects on donation rates, 12, 49 effects on patient survival rate, 12-13 effects on small transplant centers, 43-45, 46 effects on waiting times, 3, 27-28, 61 goals, 2-3, 23, 26 liver allocation policies, 25 major provisions, 24-25 mandated review, 3, 27-29 monitoring, 95 origins of, 23

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule policy development provisions, 25-26 procedural requirements, 25 recommendations for allocation, 6, 10 text, 25 Follow-up, posttransplant medication compliance, 41 posttransplant survival rate and, 98 Funeral expenses, 58 G Gender differences, 86 posttransplant survival rate, 98 Geographical area of transplantation current concerns, 2, 24 current liver allocation policy, 25, 37 current system, 5 effect on donor behavior, 12, 50, 52-53 regional variation in waiting times, 62 size, 1 system evolution, 19, 22-23 See also Organ allocation areas H Health and Human Services, Department of, Final Rule, 2, 3, 23, 24 -25 information management role, recommendations for, 15, 135 National Organ and Tissue Donation Initiative, 18 OPO standards, 34 oversight role, recommendations for, 14, 133 scientific review of transplantation system, 133 Health Care Financing Administration, 18, 34, 57 OPO oversight, 58, 132 Heart transplantation, 29 Medicaid coverage, 45 pretransplantation mortality, 93 primary nonfunction, 91 survival rates, 17 Hispanic patients access to transplantation, 44 organ donation rates, 50-51 Histocompatibility testing, 42 I Immunosuppressive medications, 41 Information management computer simulation of allocation system, 95-96 cost data, 124 current inadequacies, 14, 131, 133-134 distribution of data, 134 Final Rule goals, 2-3, 24 goals, 132 impact of biological factors, 94 organ recovery and distribution, 94 outcomes data, 94, 132-133 public access, 25, 134 recommendations for, 15, 131, 134-135 regular review of procedures and performance, 134 scientific review of transplantation system, 133 for system oversight, 131-132 for system performance evaluation, 134 transplant center-based measures, 95 See also Performance measures Insurance, access to transplantation and, 12, 39, 47 Ischemic time, 12 current knowledge and transplant practice, 92, 93-94, 98-99 definition, 17, 91 maximal achievable, 93 medically acceptable, 93 negative outcomes related to, 91, 92 organ sensitivity, 91 primary nonfunction and, 91 significance of, 17 strategies to reduce, 92 K Kidney transplantation, 91 Medicaid coverage, 45 racial differences, 39-40, 41, 42 socioeconomic differences, 41

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule L Legal liability, 3, 28 Length of stay, 127-128 Liver transplantation allocation criteria, 25, 34, 35-37 organs recovered but not transplanted, 95 reducing retransplantation risk, 92 as unit of analysis, 28-29 Local units, 32 Lung transplantation, 29 Medicaid coverage, 45 survival rates, 17 M Marginal donors, 93 Match system, 34-35 definition, 32 Medicaid, 22 access to transplantation and, 45-46 mandated referrals for organ donation, 57 Medicare, 18, 22 Final Rule effect on expenditures, 128 mandated referrals for organ donation, 57 performance standards, 132 Minority populations access to transplantation, 2, 11-12, 39-40, 44 Final Rule review, 27-28 See also specific racial or ethnic group Mortality. See Pretransplantation mortality; Survival rate, posttransplant Multiple organ transplants, 36 N National Marrow Donor Program, 95 National Organ and Tissue Donation Initiative, 18 National Organ Transplant Act of 1984, 2, 14, 17, 22 O Omnibus Budget Reconciliation Act of 1986, 22, 57 OPOs. See Organ procurement organizations OPTN. See Organ Procurement and Transplantation Network Organ allocation areas biological constraints, 94 computer simulations, 96 costs of increasing, 123, 129-130 effect on donor behavior, 12 patient education, 90 population size, 7, 61, 88 rationale for, 87-89 recommendations for, 6-7, 89-90 Organ Procurement and Transplantation Network (OPTN) allocation policy, 36-37 board composition, 25-26 criticisms of governance structure, 38 current system, 5 Final Rule provisions, 24-25, 46 historical evolution, 22-23 information management, 25, 134-135 performance measures, 133 performance review, 132 policy development, 25-26 recommendations for, 15, 134-135 review of policies and procedures, 3, 23 transition to new policies, 25 Organ procurement organizations (OPOs) administration and management, 33 certification, 18, 34 costs of organ procurement, 129-130 current system, 4 definition, 32 function, 4, 32, 33 historical evolution, 18-19, 22 host, 32 number of, 7, 32 oversight, 18, 25, 33, 58 performance standards, 34, 58-59, 132, 133 responsibilities, 19, 33, 49 service area requirements, 33 sharing agreements, 33-34 effects on transplantation rate, 82, 85 recommendations for, 89-90

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule size of distribution, 78 distribution of patient status levels, 81-82 historical evolution, 19 rationale for minimum organ allocation areas, 87-89 transplant outcomes and, 78, 81, 86 transplantation rate and, 7, 78, 81-82, 86 variation in posttransplantation mortality among, 70, 74 variation in pretransplantation mortality among, 69-70, 74, 76 variation in transplantation rate among, 6-7, 69, 70, 72, 74, 76, 78, 81-82, 85, 86-87 variation in waiting times among, 61, 67, 68, 72, 74, 86, 88-89 volume of posttransplant survival rate and, 91, 98, 99 transplant outcomes related to, 6-7, 12-13, 72, 76, 86, 88 transplantation rate and, 6, 72, 74, 76, 86, 87-88 waiting time effects on, 72 Oversight federal role, 131-132, 133 OPO certification, 18 OPO performance standards, 34, 58-59 OPO service area requirements, 33 OPTN role, 25 participants, 131 recommendations for, 14, 131, 133 scientific review of transplantation system, 133 P Pancreas transplantation, 45 Payment for donations, 58 Performance guidelines, 95 Performance measures, 14 outcomes, 132-133 purpose, 132 recommendations for, 131, 133 review of current, 132 waiting times as, 1, 7, 10, 61, 88 Posttransplantation mortality. See Survival rate, posttransplant Pretransplantation mortality, 1 effects of OPO sharing agreements, 82, 83 as indicator of access, 10 national organ sharing and, 96 OPO size and, 78, 81 OPO volume and, 6, 7 patient age and, 86 variations among OPOs, 69-70 variations by patient status, 68, 69-70, 71-72, 74, 76, 82, 85, 86 , 87 waiting time and, 72 Primary nonfunction definition, 91 ischemic time limits, 92 reducing risk of, 92 Pritsker computer model, 96 Procurement of organs costs, 123, 129-130 determination of organ acceptability, 93 factors affecting organ availability, 50 OPO responsibilities, 4, 19, 49 process, 49 reducing retransplantation risk in, 92 system evolution, 18-19 Public awareness campaigns, 53, 56, 58 Q Quality assurance, 95, 131 Quality control, 95 R Recovery and preservation of organs biological factors in, 91 costs, 129-130 current policies and procedures, 4 data collection, 95 organs recovered but not transplanted, 95 responsibility for, 4, 129 surgical procedure, 129 Required request legislation, 56-57

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule Retransplantation, 91 cost of Final Rule, 127, 129 donor characteristics as risk factors, 93 risk associated with increased allocation areas, 123 risk reduction, 92 Routine notification legislation, 57 S Severity of illness access issues in small transplant centers, 43 allocation criteria, 10, 35, 36-37 classification system, 4 cost of transplantation related to, 13, 127-129 current inadequacies in assessment, 24 current organ allocation process, 5, 6 in determination of organ acceptability, 93 effects of increased allocation areas, 1, 7 outcomes analysis method, 66-68 posttransplant survival rate and, 98 standardized criteria for defining, 26 variation in outcomes, 68, 78 waiting time and, 1, 10-11, 35, 61-62 See also specific status level of patient Socioeconomic differences access to transplantation, 2, 39-40, 41 policy development to reduce, 26 in posttransplantation compliance, 41 Sources of donated organs, 49 determination of organ acceptability, 93 State laws and policies, 27 mandated referrals for organ donation, 56-57 Medicaid, 45-46 Status 4 patient outcomes, 74 Status 1 patients access issues in small transplant centers, 43 allocation criteria, 10 characteristics of patients, 62, 69 clinical features, 4 cost of transplantation, 13, 127-128 current allocation process, 5 effects of increased organ allocation areas, 1, 7, 87-88, 96 effects of OPO sharing on transplant outcomes, 82 length of stay, 127-128 OPO size as outcome factor, 78, 81 posttransplantation mortality risk, 69, 70, 98 pretransplantation mortality risk, 68, 69-70, 71-72 transplantation rate among, 1, 69, 78, 86, 87 waiting time, 10, 61-62, 66, 68, 69, 86 Status 2 patients access issues in small transplant centers, 43 age as outcome factor, 72 allocation criteria, 10, 11, 90 characteristics of patients, 62 clinical features, 4 cost of transplantation, 13, 128 current allocation process, 5 effects of increased organ allocation areas, 1, 7, 87-89 effects of OPO sharing on transplant outcomes, 85 length of stay, 128 OPO size as outcome factor, 81 outcome predictors, 6 posttransplantation mortality risk, 72, 98 pretransplantation mortality risk, 68, 72, 74, 76, 87 transplantation rate among, 1, 72, 74, 76, 86, 87 waiting time, 10, 61-62, 66, 68, 72, 74, 86 Status 3 patients age as outcome factor, 76 allocation criteria, 10, 11, 90 characteristics of patients, 62 clinical features, 4 cost of transplantation, 13, 128 current allocation process, 5 effects of increased organ allocation areas, 1, 7, 87-89, 96 effects of OPO sharing on transplant outcomes, 85 length of stay, 128 OPO size as outcome factor, 81

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule outcome predictors, 6 posttransplantation mortality risk, 74 pretransplantation mortality risk, 68, 74, 87 transplantation rate among, 1, 74, 76, 78, 86, 87 waiting time, 10, 61-62, 66, 68, 74, 86 Steatotic livers, 92 Surgical procedures, 129 Survival rate, posttransplant biological factors in organ function, 91 data sources, 96, 98 Final Rule effects on, 12-13, 27-28, 91 method of analysis, 66-68 national organ sharing and, 96 OPO-specific risk factors, 98, 99 OPO volume related to, 12-13 racial differences, 42 risk factors, 98 status level of patient and, 98 trends, 17 variation among OPOs, 70 variations by patient status, 69, 70, 72, 74 waiting time and, 72 System of organ transplantation, 31 allocation process, 34-37 biological constraints, 94 computer simulation, 95-96 criticisms of governance structure, 38, 131 data collection and performance monitoring, 95, 131-135 evolution of, 18-23 federal role, 131-132 liver transplantation as representative of, 23 local variation, 22, 23 participants, 49 recommendations for, 14 scientific review of, 133 transplant centers and programs, 22 T Training of medical professionals, 26 Transplantation centers costs of organ procurement, 129-130 data collection, 95 definition, 32 number of, 22 performance standards, 132, 133 small, effects of Final Rule on, 43-45, 46 Transplantation programs, 3-4 definition, 32 estimated charges, 124 number of, 22 Transplantation utilization, 2 trends, 17 Transportation of patient as barrier to utilization, 44-45 Medicaid coverage, 45-46 Transportation of procured organ costs, 13, 123, 129-130 Transportation of surgical team, 129 U United Network for Organ Sharing (UNOS) criticisms of governance structure, 38 current structure, 22, 31 data collection and management, 134 function, 5, 31 liver allocation policy, 36-37 membership, 31 policy development, 31 Utilization number of transplantations, 2, 17 patient's travel distance as factor in, 44-45 trends, 17 W Waiting list, 2, 17-18 enrollment process, 3-4 Final Rule goals, 24, 26 management of, 5 multiple listings for same patient, 36 Waiting time as allocation criterion, 10-11, 35, 87, 88-89, 90 current concerns, 1, 61 definition, 61

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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule determinants of, 27 fairness issues, 2 Final Rule goals, 26 Final Rule review, 3, 27-28, 61 as indicator of system performance, 1, 7, 10, 61, 88 method of analysis, 66-68 racial differences, 40 regional variation, 23, 61, 62 socioeconomic differences, 39-40 transfer to another transplant center, 36 transplant outcomes and, 72, 74, 76, 86, 89 variation among OPOs, 61, 67, 68, 72, 74, 86, 88-89 variations by patient status, 68, 69, 72, 74, 86, 88-89